Author Archives: Julian Upton

EU Clinical Trials Agreement 'Compromised', Says Industry

European Union (EU) regulators reached agreement today on the much-vaunted Clinical Trials Regulation. The regulation harmonizes the rules for the conduct of clinical trials in the EU and the ‘acceptability’ of the resulting data, and palces further safeguards on the safety of trial subjects. The legislation’s aim is to facilitate and expedite the authorization procedure […]
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FDA Push for TRF Therapies Will 'Disrupt Pain Market'

FDA’s push for abuse-resistant opioid formulations will disrupt the pain market, say analysts Frost & Sullivan. The opioid market is currently dominated by non-tamper resistant formulations (TRFs), but FDA’s promotion of TRF therapies “could well result in the departure of non-TRF therapies from the market and shake up its structure.” Unless FDA mandates TRF therapies, […]
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Global Parkinson's Disease Market to Drop by $0.5 Billion by 2019, Says Report

The global Parkinson’s Disease market will decline from $3.4 billion in 2012 to $2.9 billion by 2019 (a negative Compound Annual Growth Rate of 2.3%), according to a new report by GBI Research (New York, NY). With PD drugs such as Azilect (rasagiline mesylate), Stalevo (levodopa, carbidopa, entacapone) and Comtan (entacapone) set to lose their […]
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Every Tenth New European Drug Developed in Finland

The number of drugs developed in Turku, Finland and granted marketing authorizations this year now stands at three, with a fourth expected to follow. The FDA has granted market authorization for the IUD Skyla, developed by Bayer and intended for women who have not given birth, and Hormos Medical’s Ophena for postmenopausal symptoms. The European […]
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EMA Sets Budget and Priorities for 2014, Promotes Transparency

In a bid to improve transparency in 2014, the European Medical Agency’s December Management Board Meeting cleared the way for the publication of the agendas and minutes of the Agency’s Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Advanced Therapies (CAT). This week the EMA […]
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